Strados Labs | Nick Delmonico, President & CEO

Nick Delmonico  0:00  
Everyone, my name is Nick Delmonico. And I am the CEO, and co founder of Strados. Labs, and at Strados labs, we believe in making every breath count. And the reason why that is our story is because of my journey as a patient. I was diagnosed with severe asthma when I was four years old. And I know what it feels like to not know my symptoms, when I'm wheezing, coughing and have insurance of breath. And whether or not it's time to go and seek hospitalization or care. And I'm not alone in having a problem like this. And this is a big problem. Over a billion people worldwide suffer from chronic respiratory diseases and respiratory infectious diseases, as we all know, in the era of COVID. But the key challenges are very consistent, right? Is when our patients experiencing symptoms? And are they getting better or worse, and we lack the technology today to objectively quantify this information before it's too late. So we have lagging indicators of pulmonary function by way of episodic diagnostics, pft tests, or, for example, peak flow. But that's not the right storyline, right is what is really happening with the patient or coughs getting worse as it getting more intense. And what's really happening when they leave the four walls of a hospital. So the care is centralized, right pulmonologists and primary care physicians, they see their patients, they try to treat them, and they send them back home. And that is where the challenges lie. Patients are reporting their symptoms subjectively, and about 40% of patients either under or over report what's happening. My CMO likes to say that men lie and women forget. But it's a difficult challenge. And so we wanted to come up with a solution that is objective. And similar to how, for example, a diabetes patient can monitor continuous glucose or heart failure patient can monitor ECG through by way of Holter. And so that's why we created the Stratus device. It's a small wearable patch that acts very similar to a stethoscope with being worn on the body and monitoring this information over time. So you get an objective sense of what's happening with a patient wherever they may be. And that information can be shared with a clinician in real time. So it's really simple to use. You place it on, you configure it, you connect it and then we collect the data. And what exactly is that data? It's long sounds, it's breathing patterns, right? It's almost exactly what you would get if you had a doctor or clinician in front of you with their stethoscope. But we're really unlocking the value of a stethoscope and making it into a patient facing solution.

And patients are excited about this. We didn't start building anything until we heard from patients that yes, this is a problem. And yes, a wearable device would be helpful for me. And we asked them what kind of device and what form factor where to put the buttons, how thin it needs to be. And so patients say they like it's small, it's lightweight, and it gives them more freedom. And that's part of our patent pending design and utility solution that we've developed. We have an amazing team here at Strados. We have my COO, CIO Richard Powers, who was with CardioMEMS previously, was the CIO there, he worked with Jason Kroh for 13 years at CardioMEMS, developing a pulmonary artery pressure implant that was successfully commercialized and ultimately exited the St. Jude Medical for nearly half a billion dollars in 2014. And our chief medical officer, Dr. Mitchell Glass is a pulmonologist and he's put five drugs on the market by way of Big Pharma and small Pharma. We have also amazing advisors to our team, both clinical and strategic on our board is Dr. Dr. Albert Rizzo. He is a pulmonologist by training and the CMO of the American Lung Association. And Steve Bishop is the former CEO of Procter and Gamble healthcare. And so we've got great stewardship here at Stratos, and real visionary thinkers about how we can change pulmonary care for the better in again, this changing environment and I'd like for you to hear directly from Dr. Rizzo why he thinks what Strados is doing is so exciting.

Dr Albert Rizzo  4:15  
Diagnose something earlier, it allows us to intervene earlier and potentially change the course of the disease. And that may be something even anytime that we can diagnose something earlier. It allows us to intervene earlier and potentially change the course of the disease. And that may be something even as simple as noticing that somebody is developing lung disease and making them stop smoking. The other extreme is the person who is having a shortness of breath episode stabilized but now it's slowly worsening. And rather than coming in every 15-30 minutes, 40 minutes checking a peak flow, listening to the lungs with a nurse at the bedside, we can now have something that is potentially going to give us real time interaction that is archivable that we can look back over the course of several days to assess and compare to what's going on right now. And the way that artificial intelligence and deep learning and all these analytics that you mentioned, are developing, that's going to ultimately give us the ability to say, this is looking like somebody who's going to need intervention quicker than we thought. So I think that's the predictive value of getting a lot of data and letting the machine figure out what this analysis looks like.

Nick Delmonico  5:30  
And then I just want to show you to what this platform is right? It's always difficult, because we're an audio platform to sort of visualize what we do. But this is what it looks like, as I showed you small wearable patch Bluetooth connected to a smartphone, we analyze acoustic data, and we have a machine learning process that determines which type of events occur throughout each sound file. And that has been validated clinically by board certified pulmonologists. So we can pick up coughing, wheezing, other adventitious breaths in real time. And so on our platform, you'll see trends associated with the number of events that are occurring with patients each and every day. And I'll let you listen to a couple of the sounds as well.

So as you could hear, that was a cough, but there's other interesting adventitious breasts in there as well, raucous roles, all of that has been categorized, and clinically validated and published as part of four publications to the American Thoracic Society, in May of this year, so we're really excited about the data that we've been able to, to collect. And again, what does that kind of look like over time for patients, this is a study we did in heart failure, COPD, at the initial admission, you see this baseline that's running across the bottom of the screen. That's how many events the patient had when he came in. And what you can see is that those events continue to go up crackles, for example, which is fluid buildup in the lungs, throughout the entire duration of the initial admission, that patient, not surprisingly, was readmitted within a week, with a whole lot of adventitious and noisy breath sounds. And unfortunately, this is a patient who passed away in the hospital from a heart failure event. But we were able to see and track these changes from the initial admission throughout the entire duration of the stay and you know, the PI's and that studies that we probably could have done something interventional here, had we seen this data live in real time. And so that's where we're going next. And we're super excited about those results. And this is data that's been funded from NSF SBIR research.

So what is it that we do and how do we make money, one of the key things that we are doing now is we actually work with pharmaceutical companies to objectively collect all of these adventitious breath sounds, and provide that back to the trial sponsors. It's a hardware software and support services cost. And that is a it's about a $780 million opportunity right now in respiratory clinical trials. And nurses are excited about this. Patients are excited about this and doctors it's really easy to use. And that's why it's getting so much interest, both clinically and from research is that you can implement it in real world and decentralized clinical trials. And as part of remote patient monitoring. I mentioned the beachhead opportunity, again, about $780 million opportunity for respiratory clinical trials. The target areas we specifically look at is when wheezing and coughing are part of the endpoint structures for their studies. And that's about a $70 million market opportunity.

We've done over a million dollars to date in in contracts with pharma companies, and we have a $10 million pipeline. And that gets us really to where we want to go next. Right, and that's to expand into telepulmonary care. So this is a product that is capable of being monitored and managed throughout the entire patient journey and solve a really big problem for for respiratory patients worldwide. We're actively looking for strategic investment from med tech sponsors, digital health, and payers. And we hope that you join us on our journey to make every breath count. Thank you